The acquisition of B. Braun Medical AG Switzerland’s manufacturing assets will advance the launch of personalized skin regeneration therapy, EpiDex, says Healiva.
Healiva, a firm that delivers medicine for individuals with chronic and acute wounds, has acquired pharmaceutical device company, B.Braun’s, manufacturing assets for an undisclosed fee. The acquisition includes a qualified cell bank, which Healiva says is vital for the GMP-compliant production of its first cell therapy product, EpiDex.
According to Healiva, the acquisition of a qualified fibroblast cell bank that passes the regulatory requirements for Advanced Therapy Medicinal Products (ATMPs) and has already received authorization for the commercial manufacture of EpiDex significantly advances the firm’s product development.
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“This transaction will enable Healiva to accelerate the launch of EpiDex, which is projected for Q4 2023,” said Priyanka Dutta-Passecker co-founder and CEO of Healiva.
“This will allow us to deliver our clinically proven, surgery-free solution to patients with severe chronic wounds more promptly, shortening the path to market for EpiDex by approximately one year.”
Healiva says that in order to manufacture Epidex, progenitor keratinocyte cells are taken from a patient’s hair and after this step they are cultured with fibroblast feeder cells, which then create small discs of autologous epidermis. The generated discs are then able to be applied onto the wound to aid growth and healing of the skin.
EpiDex had already been approved for use in the Swiss market and looks to launch there first, pending authorization from Swissmedic. After this, Healiva will look to follow the same steps in Germany and other countries in Europe.
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